Development and Clinical Validation of Early-stage Lung Cancer Prognostic Kit and Immunotherapy Companion Diagnostic Laboratory Developed Tests

What this Trial Is About

Lung cancer remains the leading cause of cancer deaths worldwide despite advances in treatment and screening. In Taiwan, less than half of lung cancer cases are diagnosed early, and about 30% of stage IB patients still experience recurrence and spread. Researchers are building on the International Cancer Moonshot Project's discovery of a new "late-like" subtype of early-stage lung cancer that signals higher risk, aiming to turn these findings into clinical tools. This observational study is sponsored by Chung Shan Medical University to validate new diagnostic kits based on this discovery for early-stage lung cancer patients. The study will develop and test two types of prognostic kits: an immunohistochemistry (IHC) kit that uses tumor tissue samples and an ELISA kit that uses blood samples. These kits aim to identify high-risk early-stage lung cancer patients who might have worse outcomes. Participants include patients who had surgery for lung adenocarcinoma at certain early stages (IA to IIIA) and will be followed after surgery to monitor recurrence. The study collects tumor tissue, blood, and other body fluids for analysis. Participants will be monitored over five years for disease-free survival, with overall survival followed for ten years. The study involves regular follow-up visits to collect specimens and evaluate patients' health status. Researchers will measure how accurately the kits predict lung cancer recurrence and survival outcomes. The study does not involve experimental treatments but focuses on validating new diagnostic methods to improve early detection of high-risk patients.

Development and Clinical Validation of Early-stage Lung Cancer Prognostic Kit